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Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression

NCT00083954•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion Criteria

•More than 8 mood episodes in the past year from screen (visit 1);
•A current Axis I disorder other than bipolar disorder within 6 months of screening;
•patients with clinically significant abnormal laboratory findings in the investigator's judgment

Locations (36)

Research Site

Birmingham, Alabama, United States

Research Site

Scottsdale, Arizona, United States

Research Site

Cerritos, California, United States

Research Site

Garden Grove, California, United States

Research Site

San Diego, California, United States

Research Site

Torrance, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Maitland, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Winter Park, Florida, United States

Key Dates

Start Date

June 1, 2004

Completion Date

August 1, 2005

Last Updated

January 4, 2013

Enrollment

530

Estimated participants

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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